Patients with aortic valve disease and ascending aortic dilation have two separate, but interrelated disease processes which require surgical replacement or repair. In these patients, replacement or repair of the valve without therapeutic intervention on the dilated aorta condemns the patient to catastrophic lethal events such as aortic dissection or rupture. Likewise, therapeutic intervention of the ascending aorta without repair or replacement of the stenotic or regurgitant aortic valve leaves the patient with symptomatic shortness of breath, heart failure, and eventual death.
Patients with aortic valve disease who are at high risk for classic open aortic valve replacement are offered a minimal-invasive treatment option—transcatheter aortic valve replacement (TAVI). A current contraindication for TAVI is concomitant ascending aortic ectasia/aneurysm. There are two potential disadvantages of isolated TAVI in patients with concomitant ascending aorta dilatation. First, TAVI which requires intra-aortic manipulation utilizing wires, catheters, and deployment devices can result in catastrophic outcomes such as acute aortic dissection or rupture of the diseased, dilated ascending aorta. Second, as mentioned, patients with aortic valve disease and ascending aortic dilatation have high risk of spontaneous aortic dissection or rupture. TAVI treatment for aortic valve disease in patients with concomitant ascending aortic dilatation does not eliminate the risk of catastrophic aortic events such as aortic dissection and aortic rupture.
Above-mentioned reasons show why it is essential to replace both the dilated ascending aorta and diseased aortic valve simultaneously. Since completing TAVI with endovascular ascending aortic repair is still challenging and not well established, these patients despite their high risk for cardiac surgery undergo open surgery or continue medical treatment only.
It is the objective of this invention to provide a single device for minimally invasive treatment of both aortic valve and ascending aortic disease in a one-stage procedure.